Not provided
Not provided
Not provided
Not provided
Not provided
Lack of accrual
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to see if giving the patient stem cells their original donor (boost) after removing the T cells (T cell depleted- TCD boost) without further chemotherapy. The investigators want to see if this can improve bone marrow function. This would also improve the patients white blood counts, red blood counts and platelets. This may make the patients chances of improving and surviving better. The investigators will also be looking at the short term side effects and risks of the TCD boost.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active infection and/or organ compromise or GVHD. | Experimental | This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation. |
|
| active infection, active or controlled GVHD &/or organ compro | Experimental | This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donor peripheral blood progenitor cells: stimulation, harvesting, isolation and T-cell depletion | Procedure | For related donors, beginning 5-6 days before the day of HPC(A) or HPC (M) TCD boost infusion, the normal donor will receive GCSF per institutional guidelines. On the fifth and sixth days of this course of G-CSF, the donor will undergo daily leukapheresis designed to provide a minimum of 5x10^6 CD34+ cells/kg of the transplant recipient's weight. For unrelated donors, the G-CSF will be administered and the leukapheresis obtained according to the National Marrow Donor Program protocol IND, and institutional guidelines. Mononuclear cell fractions (i.e., CD34+ cells) collected on the fourth and fifth days will be pooled. |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Blood Counts Recovery (Response Will be Defined by Stable Blood Counts (ANC>1000, Hb>8 With Absolute Reticulocyte Count>20x10^9/L ,and Plt>50,000) Without Support of Blood Product Transfusions and/or Growth Factors. | will be documented by CBC checks every 2 weeks. Response will be defined by stable blood counts (ANC>1000, Hb>8 with absolute reticulocyte count>20x10^9/L ,and Plt>50,000) without support of blood product transfusions and/or growth factors. | 1 year |
Not provided
Not provided
Inclusion Criteria:
Patients who are diagnosed with PGF are candidates for this trial.
Patients who underwent transplant at another facility and suffer from PGF will be eligible as well as long as a donor is available. PGF can be primary (no counts recovery after the preparative regimen) or secondary (cytopenia after engraftment has occurred).
Patients with auto-immune cytopenia with auto antibodies to neutrophils or platelets or positive Coombs test that did not respond to immunosuppressive agents within 3 months from initiation of therapy are eligible as well.
Persistent cytopenia requiring growth factors and/or blood products AND evidence of hypocellular BM (<25%). Persistent cytopenia (at least 4 weeks period) is defined by presence of TWO of the following:
This criteria for persistent cytopenia and hypocellular bone marrow does not apply to patients with auto-immune cytopenia, ONLY PGF patients
Exclusion Criteria:
Patients will be excluded from the trial if at time of enrollment:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roni Tamari, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
Not provided
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | No Active Infection and/or Organ Compromise or GVHD. | This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 2, 2015 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| CliniMACS Cell Selection System | Device |
|
| FG001 |
| Active Infection, Active or Controlled GVHD &/or Organ Compro |
This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | No Active Infection and/or Organ Compromise or GVHD. | This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation. |
| BG001 | Active Infection, Active or Controlled GVHD &/or Organ Compro | This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peripheral Blood Counts Recovery (Response Will be Defined by Stable Blood Counts (ANC>1000, Hb>8 With Absolute Reticulocyte Count>20x10^9/L ,and Plt>50,000) Without Support of Blood Product Transfusions and/or Growth Factors. | will be documented by CBC checks every 2 weeks. Response will be defined by stable blood counts (ANC>1000, Hb>8 with absolute reticulocyte count>20x10^9/L ,and Plt>50,000) without support of blood product transfusions and/or growth factors. | No data were collected | Posted | 1 year |
|
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Active Infection and/or Organ Compromise or GVHD. | This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation. | 1 | 2 | 2 | 2 | 2 | 2 |
| EG001 | Active Infection, Active or Controlled GVHD &/or Organ Compro | This protocol includes two single-arm phase II trials to assess the efficacy and confirm the safety of administration of TCD stem cell boost or bone marrow (BM) HPC (M) boost from the original donor for patients with poor graft function after allogeneic hematopoietic stem cell transplantation. | 1 | 2 | 1 | 2 | 1 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial tamponade | Cardiac disorders | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Hematoma | Vascular disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Creatinine increased | Investigations | Systematic Assessment |
| ||
| Pericardial tamponade | Cardiac disorders | Systematic Assessment |
| ||
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roni Tamari, MD | Memorial Sloan Kettering Cancer Center | 212-639-5987 | tamarir@mskcc.org |
| Apr 5, 2018 |
| Prot_SAP_000.pdf |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|